TY - JOUR
T1 - Acceptability of a dapivirine gel administered rectally to HIV-1 seronegative adults (MTN-033 study)
AU - MTN-033 Protocol Team
AU - Bauermeister, José A.
AU - Tingler, Ryan C.
AU - Johnson, Sherri
AU - Macagna, Nicole
AU - Lucas, Jonathan
AU - Dominguez-Islas, Clara
AU - Szydlo, Daniel
AU - Ngo, Julie
AU - Jacobson, Cindy E.
AU - Kramzer, Lindsay
AU - Singh, Devika
AU - Dezzutti, Charlene S.
AU - Kunjara Na Ayudhya, Ratiya Pamela
AU - Piper, Jeanna
AU - Devlin, Bríd
AU - Hendrix, Craig W.
AU - Ho, Ken
N1 - Funding Information:
José A. Bauermeister and Ryan C. Tingler are affiliated with the University of Pennsylvania, Philadelphia, Pennsylvania. Sherri Johnson, Nicole Macagna, and Jonathan Lucas are affiliated with FHI 360, Durham, North Carolina. Clara Dominguez-Islas is affiliated with the Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, Washington. Daniel Szydlo and Julie Ngo are affiliated with the Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, Seattle, Washington. Cindy E. Jacobson, Lindsay Kramzer, Devika Singh, Charlene S. Dezzutti, and Ken Ho are affiliated with the University of Pittsburgh, Pittsburgh, Pennsylvania. Char-lene S. Dezzutti and Craig W. Hendrix are affiliated with the Microbicide Trials Network, Pittsburgh, Pennsylvania. Ratiya Pamela Kunjara Na Ayudhya is affiliated with the University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania. Jeanna Piper is affiliated with the Division of AIDS/NIAID/ NIH, Bethesda, Maryland. Craig W. Hendrix is affiliated with Johns Hopkins University School of Medicine, Baltimore, Maryland. Bríd Devlin is affiliated with the International Partnership for Microbicides, Silver Spring, Maryland. The study team gratefully acknowledges the study participants of MTN-033 and the International Partnership for Microbicides and Microbicide Trials Network for providing the study product. The study was designed and implemented by the Microbicide Trials Network (MTN). The MTN is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with cofunding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Address correspondence to José Bauermeister, 418 Curie Blvd., Room 222L, Philadelphia, PA 19104. E-mail: bjose@upenn.edu
Publisher Copyright:
© 2021 The Guilford Press.
PY - 2021/10
Y1 - 2021/10
N2 - We triangulated quantitative and qualitative assessments to evaluate participants’ acceptability of 0.05% dapivirine rectal microbicide (RM) gel administered via two separate modalities (a rectal applicator and an artificial phallus for use as a coital simulation device) as part of a Phase I trial (N = 14) among men who have sex with men (MSM) randomized using a 1:1 ratio. Overall, participants reported favorable acceptability of the gel (n = 11; 78.6%), the same or more at the end of the study compared to when they started the study. Additionally, when discussing their preferred administration modality, they noted that both methods had positive qualities but also potential areas of improvement. Our findings underscore the need to create multiple delivery methods for a future microbicide gel (i.e., with and without the need for an applicator) and highlight the importance of offering MSM choices in how biomedical HIV prevention strategies are delivered.
AB - We triangulated quantitative and qualitative assessments to evaluate participants’ acceptability of 0.05% dapivirine rectal microbicide (RM) gel administered via two separate modalities (a rectal applicator and an artificial phallus for use as a coital simulation device) as part of a Phase I trial (N = 14) among men who have sex with men (MSM) randomized using a 1:1 ratio. Overall, participants reported favorable acceptability of the gel (n = 11; 78.6%), the same or more at the end of the study compared to when they started the study. Additionally, when discussing their preferred administration modality, they noted that both methods had positive qualities but also potential areas of improvement. Our findings underscore the need to create multiple delivery methods for a future microbicide gel (i.e., with and without the need for an applicator) and highlight the importance of offering MSM choices in how biomedical HIV prevention strategies are delivered.
KW - Behavioral congruence
KW - HIV
KW - HIV prevention
KW - Microbicides
KW - Rectal
UR - http://www.scopus.com/inward/record.url?scp=85118131646&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85118131646&partnerID=8YFLogxK
U2 - 10.1521/AEAP.2021.33.5.361
DO - 10.1521/AEAP.2021.33.5.361
M3 - Article
AN - SCOPUS:85118131646
SN - 0899-9546
VL - 33
SP - 361
EP - 376
JO - AIDS Education and Prevention
JF - AIDS Education and Prevention
IS - 5
ER -